Anastomotic device

ABSTRACT

The present invention is directed to gastrointestinal or enteric (including biliary) anastomosis and the like. The anastomotic device of the invention is a three dimensional woven tube of wire. The outer loops or ends of the tube fold or loop back on deployment in a manner which holds the luminal interface of the anastomotic site into apposition at the deployment site. The woven tube is deployed using a protective sleeve and nose assembly. Adjustment of the wire diameter and/or material properties of the wire can cause the anastomotic device to remain in place permanently or, for example, in the case of the intestine to slough through the two apposing walls of the lumen resulting in the device safely passing through the intestine leaving a naturally healed, properly functioning anastomosis.

The present application is a continuation-in-part of application Ser.No. 10/175,159, filed Jun. 20, 2002, which claims the benefit ofprovisional application Ser. No. 60/299,618, filed Jun. 20, 2001.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is directed to gastrointestinal and enteric(including biliary) anastomoses and the like. The woven tube of wire ofthe invention is a three dimensional structure wherein the outer loopsor ends of the woven tube fold or loop back in a manner which holds theluminal interface of the anastomotic site into apposition at thedeployment site. The woven tube, depending on material utilized, couldeither hold the lumen walls in apposition as a permanent fixtureeventually incased by scar tissue or remain in place temporarily untilsufficient healing occurs between the walls of the intestine, forexample, at which time the anastomotic device sloughs from the intestineand is safely passed, leaving a properly functioning anastomosis.

2. Description of the Related Art

Surgical procedures often require the joining (anastamosis) of twovessels or hollow vicera. For example, a permanent anastomosis betweenthe stomach and intestine may be required in the performance of gastricbypass surgery for the morbidly obese as well as to alleviate blockagein the common bile duct by draining bile from the duct to the smallintestine during surgery for pancreatic cancer. Surgical anastomosisgenerally involves manual suturing of the two structures. This processcan be technically demanding and time consuming. This complex surgicalprocedure is even more challenging during minimally invasive surgery(MIS) where the surgeon is required to use instruments that are poorlydesigned for this task.

SUMMARY OF THE INVENTION

The present invention is directed to a woven tube of wire for use in anautomated anastomotic delivery device for surgery with special emphasison MIS. The primary component is the woven tube of wire which deforms tomake an anastomotic device when inserted into the walls of two adjacentvessels or lumens. The use of such a device for joining (anastomosing)two gastrointestinal or enteric (including biliary) vessels or lumens orthe like is new.

The anastomotic delivery device is designed with a protective sleeve toencapsulate the woven tube and a removable nose assembly to permit thewoven tube to be inserted into the protective sleeve via a loadingapparatus. The woven tube is pulled longitudinally causing the tube tobecome longer and very small in diameter and is installed into a loadingapparatus. The loading apparatus consists of a sheath and attachedalignment cylinder and a plunger. The loading apparatus is designed tofit over the end of the protective sleeve of the delivery device topermit ease of reloading for multiple deployments. To load the woventube into the delivery device, the nose assembly is removed from thedelivery device and the loading apparatus is fit over the protectivesleeve. The plunger of the loading apparatus moves the woven tube intothe protective sleeve of the delivery device. After the woven tube isinstalled in the delivery device, the nose assembly is placed over theprotective sleeve to encapsulate the woven tube between the noseassembly and a ram.

The loaded delivery device is inserted into the appropriate vessel orlumen either manually or with the aid of a previously positioned guidewire. A small sharp knife, initially retracted in the center of the noseassembly, is exposed at the tip (such as by pushing on a button in thehandle) in order to assist the surgeon when passing the delivery devicethrough the walls of the vessels or lumens. The nose assembly andprotective sleeve penetrate both walls and are properly positioned withthe tissues against an alignment sleeve on the delivery device whichserves as a tissue stop at this point in the procedure. The woven tubeis then partially deployed from the protective sleeve by movement of theram, while simultaneously the alignment sleeve positions the tissuesonto the woven tube. Once the tissues are in proper position, the woventube is completely deployed from the protective sleeve whilesimultaneously alignment struts or an alignment buttress mechanisminsures proper positioning of the tissues during closure of the woventube. Closure of the woven tube is accomplished by forces resulting fromshape memory or spring metal properties of the woven tube and/or bycompression of the woven tube by the delivery device which can supplyforces against the petals of the woven tube to insure a properlyfunctioning anastomosis.

The mechanical force of the woven tube against the lumen walls whichcreates the anastomosis is dependent on the material utilized in themanufacturing of the woven tube. With a woven tube created from athermal shape memory alloy such as nitinol, heat from the body causesthe woven tube to contract longitudinally to produce the anastomosis.With a woven tube created from spring material, the supplied force tobold the lumen walls in apposition occurs when the material springs backto initial form. With a woven tube manufactured from compressiblematerial, the final shape of the woven tube is formed mechanically bythe compression action of the delivery device. With either approach,sufficient force is applied to the wall tissues such that the holebetween the two lumens is enlarged (for drainage) and leakage outsidethe two lumens does not occur. When used in the intestine, for example,the mechanical force from the wire mesh of the anastomotic device tokeep the lumen walls held in apposition can be varied dependent on wirediameter and/or material properties resulting in the anastomotic devicebeing either a permanent fixture or remaining temporarily in place untilsufficient healing occurs between the intestine at which time theanastomotic device sloughs from the intestine and is safely passedleaving a properly functioning anastomosis.

Additional objects, advantages and other novel features of the inventionwill be set forth in part in the description that follows and in partwill become apparent to those skilled in the art upon examination of theforegoing or may be learned with the practice of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of the woven tube of wire in its deployed form inwhich the outer loops or ends of the woven tube have deformed andeverted to form petals which hold the walls of the lumens intoapposition, the front and back petals of the deployed anastomotic devicebeing shown as dark black and light gray lines, respectively.

FIG. 2 is a side view of the woven tube pulled longitudinally prior tobeing placed into the protective sleeve of the delivery device.

FIG. 3A is a front view of the woven tube similar to FIG. 1 with thewalls of the lumens being omitted.

FIG. 3B is a side view of the woven tube of FIG. 3A.

FIG. 4A is a cross-sectional view of the delivery device inserted into abody cavity either manually or, as shown, assisted by a previouslypositioned guide wire to a predetermined anastomotic site having thewoven tube loaded inside the protective sleeve between the ram and thenose assembly with the knife deployed in preparation to puncture thelumen walls.

FIG. 4B shows the end of the delivery device piercing the lumen wallsusing the retractable knife.

FIG. 4C shows the end of the delivery device passed through the puncturecreated by the knife (now retracted) with the lumen walls over theprotective sleeve and against the alignment sleeve.

FIG. 4D shows the partial deployment of the woven tube from the end ofthe protective sleeve via the movement of the ram, nose assembly andalignment sleeve.

FIG. 4E shows the continued deployment of the woven tube via the furthermovement of the ram which promotes the expansion of the woven tube.Simultaneously, the alignment sleeve pushes the tissues from theprotective sleeve toward the center of the woven tube before fulldeployment of the woven tube.

FIG. 4F shows the final push of the woven tube from the protectivesleeve via the movement of the ram and nose assembly. Simultaneously,the alignment struts are deployed from the alignment sleeve at apredetermined angle assisting proper placement of the tissues duringclosure of the woven tube.

FIG. 4G shows the delivery device inside the woven tube deployed aboutthe lumen.

FIG. 4H shows the retraction of the alignment struts, the alignmentsleeve positioned against one side of the deployed woven tube, and thenose assembly contracted to form the compressed buttress positionedagainst the opposite side of the deployed woven tube to insure completeclosure.

FIG. 4I shows the nose assembly extended to retract the compressedbuttress and the delivery device removed from the center of the deployedwoven tube.

FIG. 4J shows the same action of FIG. 4F with the final push of thewoven tube from the protective sleeve via the movement of the ram andthe nose assembly except that an alignment buttress mechanism is usedinstead of the alignment struts. Simultaneously with the movement of theram and nose assembly, the alignment buttress mechanism is deployed overthe alignment sleeve insuring proper placement of the tissue duringclosure of the woven tube.

FIG. 5A is a cross-sectional view of the loading apparatus with thewoven tube at the end of the loading apparatus and the nose assemblyremoved from the delivery device.

FIG. 5B shows the loading apparatus in place on the end of theprotective sleeve. Movement of the plunger in the loading apparatuspositions the woven tube inside the protective sleeve.

FIG. 5C shows the woven tube loaded inside the protective sleeve of thedelivery device with the nose assembly in place.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The tube 10 has an overlapping woven design. The woven tube is designedto produce a round opening 12 between two layers of tissue 14, 16 and tohold the layers of tissue together for a watertight seal. The deployedanastomic device is essentially a woven tube 10 of wire 18 that isaxially compressed as shown in FIG. 1.

The woven tube 10 is defined by the wire diameter, number ofcircumferential and longitudinal openings or diamonds 20, the tubelength and the center diameter. The openings or diamonds 20′ at thelongitudinal ends of the elongated woven tube are referred to as petalswhen the device is in the deployed shape (see FIG. 1).

In use, the woven tube 10 is forced into an elongated form (with muchsmaller diameter than that shown in FIG. 2), placed through openingsbetween the wall tissues of two lumens and allowed or forced to returnto the flattened shape of FIG. 1. In the process, the tissues of bothlumen walls are compressed between the petals of the flattened tube (seeFIG. 1) with the center diameter 12 of the flattened tube forming anopening between the lumens.

The woven tube 10 can be applied, for example, through the common bileduct, and pushed through so that it connects the duct to the jejunum.After the connection has been made, the tube can be caused to deform andevert so that the ends spread out like the petals of a flower and form aconnection between the two ducts. The woven tube 10, depending on wirediameter and/or material properties utilized, could either hold thelumen walls in apposition as a permanent fixture eventually incased byscar tissue or remain in place temporarily until sufficient healingoccurs between the tissue layers at which time the anastomotic devicesloughs from the intestine and is safely passed leaving a properlyfunctioning anastomosis. As a general rule, a larger wire diameter willresult in greater mechanical force and a tendency for the anastomoticdevice to slough from the intestine. The material properties can bevaried, for example, by the selection of the annealing temperature ofthe wire metal to facilitate either a permanent fixture or a temporaryfixture.

The woven tube 10 may be made out of a shape memory metal. A shapememory metal is an alloy that changes its plasticity as heat is applied,allowing it to change shape. If a shape memory metal is annealed in adesired form (in a longitudinally compressed form), after it is reshaped(in a cylindrical tube form) it will return to its annealed shape(flattened form) if it is reheated at a significantly lower temperature.The very special property of thermal memory is especially helpful in thedesign of a low profile and flexible delivery system. The preferredshape memory metal is a titanium-nickel alloy, most preferably a nearlyequiatomic alloy of titanium and nickel called nitinol. Specific nitinolalloys, which also have superelastic properties, can reshape at bodytemperature.

The woven tube 10 may also be made out of a spring material. In thiscase, the supplied force to hold the lumen walls in apposition occurswhen the wire material springs back to initial form.

As a further alternative, the woven tube 10 may be manufactured fromcompressible wire material. In this case, the final shape of the woventube is formed mechanically by the compression action of the deliverydevice.

The anastomotic delivery device 22 is designed with a protective sleeve26 to encapsulate the woven tube 10 and a removable nose assembly 30 topermit the woven tube 10 to be inserted into the protective sleeve 26via a loading mechanism 42. The woven tube 10 is pulled longitudinallycausing the tube to become longer and very small in diameter and isinstalled into the loading mechanism 42. The loading mechanism 42consists of a sheath 48 and plunger 50 and includes an alignmentcylinder 52 designed to fit over the end of the protective sleeve 26 ofthe delivery device 22 to permit ease of reloading for multipledeployments. To load the woven tube 10 into the delivery device 22, thenose assembly 30 is removed from the delivery device 22 and the loadingmechanism 42 is fit over the protective sleeve 26. The plunger 50 of theloading mechanism 42 moves the woven tube 10 into the protective sleeve26 of the delivery device 22. After the woven tube 10 is installed inthe delivery device 22, the nose assembly 30 is reinstalled toencapsulate the woven tube 10 between the nose assembly 30 and acylindrical ram 36.

The nose assembly 30 includes a first hollow shaft 54 which fits in theopening of cylindrical ram 36. The nose assembly further includes asecond hollow shaft 56 which is positioned in the hollow opening of thefirst hollow shaft 54 in telescoping fashion. The nose assembly has astreamlined nose 58 and a rounded base 60. The proximal end of the firsthollow shaft 54 is attached to the rounded base 60. The proximal end ofthe second hollow shaft 56 is attached to the streamlined nose 58. Thenose assembly also has a hollow rubber or plastic cylinder 62 betweenthe streamlined nose 58 and the rounded base 60. A first stop 64 isattached to the distal end of the streamlined nose 58 and a second stop66 is attached to the proximal end of the rounded base 60.

In use in a side-to-side intestinal anastomosis, for example, thedelivery device 22 is inserted into the body cavity either manually or,as shown, with the aid of a previously positioned guide wire 38 (whichpasses through second hollow shaft 56 and an opening in knife blade 34)through a trochar or tube (not shown) and the streamlined nose 58 of thedelivery device 22 is positioned at a predetermined puncture site in afirst intestinal segment 28 either proximal or distal to the desiredanastomotic site and the delivery device 22 is advanced intraluminallyto the anastomotic site.

The second intestinal segment 32 is brought into close apposition to thefirst segment at the anastomotic site and a knife blade 34, initiallyretracted in the center of the streamlined nose 58, is used to piercethrough the wall of the first segment 28 and the wall of the secondsegment 32 and into the lumen of the second segment positioning thetissue against the alignment sleeve 40 as shown in FIG. 4C. The woventube 10 is deployed as shown in the sequences of FIGS. 4D, 4E, 4F, 4Gand 4H at the juncture of the apposing holes created by the knife blade34 and assumes the petal configuration at the site to hold the twopieces of intestine in apposition. The woven tube 10 deployed throughthe two layers of intestine is shown in FIGS. 4G, 4H and 4I. The opposedpetals 20 on opposite sides of the two layers of intestine 28, 32 arepreferably interdigitated as shown in FIGS. 1, 3A and 3B.

With reference to the sequences of FIGS. 4D, 4E, 4F, 4G and 4H, the noseassembly 30 is moved away from the proximal end of the protective sleeve26 as shown in FIG. 4D. Simultaneously, the cylindrical ram 36 and thealignment sleeve 40 are advanced toward the proximal end of theprotective sleeve 26 also as shown in FIG. 4D. The cylindrical ram 36partially forces the woven tube 10 out of the end of the protectivesleeve 26 while the alignment sleeve 40 compresses the two layers ofintestine 28, 32.

The woven tube 10 is continued to be deployed by further advancing thecylindrical ram 36 toward the proximal end of the protective sleeve 26as shown in FIG. E. At the same time, the alignment sleeve 40 isadvanced to the proximal end of the protective sleeve 26 and pushes thetissues from the protective sleeve 26 toward the center of the woventube 10 before full deployment of the woven tube.

As shown in FIG. F, the woven tube 10 is forced out of the protectivesleeve 26 by moving the cylindrical ram 36 to the proximal end of theprotective sleeve 26. At the same time, alignment struts 44 housed ingrooves in the alignment sleeve 40 are moved into a predeterminedangular position to support the intestinal walls 28, 30. The alignmentstruts 44 may be, for example, spring wire or nitinol wire in itssuperelastic phase.

FIG. G shows the woven tube 10 fully deployed. At this stage, thealignment struts 44 are still positioned to support the intestinal walls28, 30.

As shown in FIG. H, the alignment struts 44 have been retracted intotheir housing in the alignment sleeve 40. The streamlined nose 58 hasbeen moved toward the distal end of the deliver device 22 by means ofthe second hollow shaft 56. This movement causes a compression of thehollow rubber or plastic cylinder 62 which forms a compressed buttress62′ in abutting contact with the deployed woven tube 10 to ensurecomplete closure.

In order to remove the device from the deployed woven tube 10, thehollow rubber or plastic cylinder 62 is retracted into nose assembly 30by movement of the second hollow shaft 56. The delivery device 22 isthen removed from the center of the deployed woven tube 10 as shown inFIG. 4I.

FIG. 4J shows an alternative embodiment in which the alignment struts 44have been replaced with an alignment buttress mechanism 46. FIG. 4Jshows the same delivery sequence as FIG. 4F. As shown in FIG. 4J, theproximal end of the alignment buttress mechanism 46 is attached to theproximal end of the alignment sleeve 40. Thus, deployment of thealignment buttress mechanism 46 causes it to assume a loopedconfiguration insuring proper placement of the tissue during closure ofthe woven tube 10. The alignment buttress mechanism 46 may be, forexample, a plastic mesh sleeve or a plastic tube with longitudinalslits.

The foregoing description of a preferred embodiment of the invention hasbeen presented for purposes of illustration and description. It is notintended to be exhaustive or to limit the invention to the precise formdisclosed. Obvious modifications or variations are possible in light ofthe above teachings. The embodiment was chosen and described to providethe best illustration of the principles of the invention and itspractical application to thereby enable one of ordinary skill in the artto utilize the invention in various embodiments and with variousmodifications as are suited to the particular use contemplated. All suchmodifications and variations are within the scope of the invention asdetermined by the appended claims when interpreted in accordance withthe breadth to which they are fairly, legally and equitably entitled.

1. A method of deploying an anastomosis device, comprising mounting awoven tube of wire having a first end and a second end inside aprotective sleeve, inserting the device into a body cavity through atrochar or tube to a predetermined puncture site of a first segmenteither proximal or distal to a desired anastomotic site, advancing thedevice intraluminally to the anastomotic site either manually or withthe aid of a guide wire, bringing a second tissue segment into closeapposition to the first segment at the anastomotic site, piercing a wallof the first segment and a wall of the second segment and into a lumenof the second segment, deploying the tube from the protective sleeve ata juncture of apposing puncture holes created by the device, and forminga petal configuration wherein the first end and the second end of thetube form interdigitated petals at the anastomotic site to hold the twosegments in apposition.
 2. The method of claim 1, wherein the first andsecond segments are intestinal segments.
 3. The method of claim 1,wherein one of the first and second segments is a bile duct and theother of the first and second segments is the jejunum.
 4. The method ofclaim 1, wherein the anastomosis is a side-to-side anastomosis.
 5. Themethod of claim 1, wherein the mechanical force of the woven tube tohold the two segments in apposition is selected such that the deployedtube remains temporarily in place until sufficient healing of thesegments occurs at which time the tube sloughs from the segments leavinga properly functioning anastomosis.
 6. The method of claim 1, whereinthe device is advanced to the anastomotic site with the aid of apreviously positioned guide wire.
 7. The method of claim 1, wherein thetube is deployed from the protective sleeve by a ram housed in theprotective sleeve.
 8. The method of claim 1, wherein tissues are pushedfrom the protective sleeve onto the tube during deployment by analignment sleeve associated with the protective sleeve.
 9. The method ofclaim 1, wherein the tissues are properly placed during deployment ofthe tube by an alignment mechanism.
 10. The method of claim 1, whereinthe closure of the deployed tube is ensured by compression of the tubedistal from the protective sleeve.
 11. A method of deploying ananastomosis device, comprising mounting a woven tube of wire having asubstantially constant diameter between a first end and a second endinside a protective sleeve, inserting the device into a body cavitythrough a trochar or tube to a predetermined puncture site of a firstsegment either proximal or distal to a desired anastomotic site,advancing the device intraluminally to the anastomotic site eithermanually or with the aid of a guide wire, bringing a second tissuesegment into close apposition to the first segment at the anastomoticsite, piercing a wall of the first segment and a wall of the secondsegment and into a lumen of the second segment, deploying the tube fromthe protective sleeve at a juncture of apposing puncture holes createdby the device, and forming a petal configuration wherein the first endand the second end of the tube form interdigitated petals at theanastomotic site to hold the two segments in apposition.